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BIIB033 Single Ascending Dose Study in Healthy Volunteer Subjects

Sponsor
Biogen (Industry)
Overall Status
Completed
CT.gov ID
NCT01052506
Collaborator
(none)
72
Enrollment
2
Locations
2
Arms
21
Duration (Months)
36
Patients Per Site
1.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The primary objective of the study is to evaluate the safety and tolerability of single dose of BIIB033 administered to healthy adult volunteers.

Condition or Disease Intervention/Treatment Phase
Phase 1

Detailed Description

BIIB033 is an investigational product being developed to promote remyelination in subjects with multiple sclerosis (MS). This healthy volunteer study will evaluate safety and tolerability of a single dose of BIIB033.

Study Design

Study Type:
Interventional
Actual Enrollment :
72 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Randomized, Blinded, Placebo-Controlled, Single Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of BIIB033 in Healthy Adult Volunteers
Study Start Date :
Jan 1, 2010
Actual Primary Completion Date :
Oct 1, 2011
Actual Study Completion Date :
Oct 1, 2011

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: Placebo

Single dose of saline solution (8 cohorts IV; 1 cohort SC)

Drug: Placebo
Single dose of placebo comparator (8 cohorts IV, 1 cohort SC)
Experimental: BIIB033

Single, escalating doses of BIIB033 (8 cohorts IV; 1 cohort SC)

Drug: BIIB033
Single, escalating doses of BIIB033 (8 cohorts IV, 1 cohort SC)
Other Names:
  • Anti-LINGO-1 antibody

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Safety as measured by adverse event monitoring, laboratory assessments and MRI [up to 4 months]

    2. Tolerability as measured by adverse event monitoring, laboratory assessments and MRI [up to 4 months]

    Secondary Outcome Measures

    1. BIIB033 serum pharmacokinetics levels [up to 4 months]

    2. BIIB033 serum antibodies levels [up to 4 months]

    3. Exploratory blood, urine and CSF biomarkers [up to 4 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    25 Years to 55 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Must be in good health

    • BMI of 18-30kg/m2

    • Contraception required for at least 6 months after study drug administration

    Exclusion Criteria:

    • History of clinically significant disease or lab values

    • Females of childbearing potentials

    • Contraindication to brain MRI and/or lumbar puncture

    • Treatment with any prescription medication within the 28 days prior to study entry

    • Treatment with any over-the-counter products, including herbal and/or alternative health preparations and procedures within the 14 days prior to study entry

    • Regular use of any tobacco product within 3 months prior to study entry

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Research Site Glendale California United States
    2 Research Site Utrecht Netherlands

    Sponsors and Collaborators

    • Biogen

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Biogen
    ClinicalTrials.gov Identifier:
    NCT01052506
    Other Study ID Numbers:
    • 215HV101
    First Posted:
    Jan 20, 2010
    Last Update Posted:
    Jan 9, 2017
    Last Verified:
    Jan 1, 2017
    Keywords provided by Biogen
    Human volunteers

    Study Results

    No Results Posted as of Jan 9, 2017